A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity (Talisman)

Last Updated March 6, 2025

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64407564MMY2006

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 2

2
Sites
7 Sites
Status

Recruiting

SUMMARY

The purpose of this study is to identify preventive treatments that can minimize the occurrence, severity, and duration of talquetamab-related taste changes (dysgeusia), during the prophylaxis (preventive) treatment phase, and to better characterize the signs or symptoms of talquetamab-related taste changes.

CONDITIONS

Relapse Multiple Myeloma
Refractory Multiple Myeloma

ELIGIBILITY

Inclusion Criteria:

* Multiple myeloma (MM) according to IMWG diagnostic criteria
* Were triple-class exposed (received prior treatment with a PI, an IMiD, and anti CD38 mAb)
* Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
* Have an Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 or 1 at screening. Participants with ECOG-PS 2 or 3 are eligible for the study if the ECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy
* Be willing and able to adhere to the lifestyle restrictions specified in the protocol

Exclusion Criteria:

* Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
* Stroke, transient ischemic attack, or seizure within 6 months prior to screening
* Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure New York Heart Association functional classification Class III or IV. Uncomplicated deep vein thrombosis is not considered exclusionary
* Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of talquetamab, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
* A WETT score suggesting severe dysgeusia at screening. Also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. Some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Brazil, South Korea, Puerto Rico, Spain

Country (5)	City or Province (7)	Status
United States	New York Icahn School of Medicine at Mt. Sinai	RECRUITING
Brazil	Sao Paulo Instituto D Or de Pesquisa e Ensino IDOR	RECRUITING
South Korea	Seoul Seoul National University Hospital	RECRUITING
South Korea	Seoul The Catholic University of Korea Seoul St Mary s Hospital	RECRUITING
South Korea	Seoul Samsung Medical Center	RECRUITING
Puerto Rico	San Juan Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center	RECRUITING
Spain	Madrid Hosp. Univ. Ramon Y Cajal	SUSPENDED

Geo Locations

40.71427, -74.00597

-23.5475, -46.63611

37.566, 126.9784

18.46633, -66.10572

40.4165, -3.70256

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